Tolebrutinib designated breakthrough therapy by the FDA for non-relapsing secondary progressive multiple sclerosis
- The FDA has granted Breakthrough Therapy designation to tolebrutinib for treating non-relapsing secondary progressive multiple sclerosis (nrSPMS).
- This designation is based on positive results from the HERCULES phase 3 study, showing a 31% delay in 6-month confirmed disability progression compared to placebo.
- Tolebrutinib is the first brain-penetrant BTK inhibitor in MS to receive this designation, highlighting its potential to address unmet needs in nrSPMS.
- Regulatory submissions are being finalized for the US and prepared for the EU, with ongoing studies in primary progressive MS expected to report results in H2 2025.
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Newron and EA Pharma announce license agreement for evenamide in Japan and other Asian territories
- Newron Pharmaceuticals and EA Pharma have entered a license agreement for the development, manufacturing, and commercialization of evenamide in Japan and other Asian territories.
- Newron will receive up to €117 million, including an upfront payment of €44 million, and tiered royalties from EA Pharma.
- Evenamide is a novel modulator of glutamate release, showing efficacy in treatment-resistant schizophrenia (TRS) patients.
- Newron plans to initiate a Phase III one-year study in H1 2025 outside the licensed territories.
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Delix presents full results from phase 1 trial of DLX-001 at ACNP annual meeting
- Delix Therapeutics shared results from the Phase 1 trial of DLX-001, a neuroplastogen, at the ACNP Annual Meeting.
- The trial involved 106 healthy volunteers and focused on safety, pharmacokinetics, and pharmacodynamics.
- DLX-001 showed a favorable safety profile with no serious adverse events or psychotomimetic effects.
- The study supports further evaluation in ongoing Phase 1b and upcoming Phase 2 studies for psychiatric conditions.
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